Autologous Cellular Therapy With PRP-PC in Chronic Lung Diseases: An Observational Study LI-004 (PRP-PC)

September 28, 2022 updated by: H-CYTE
For this study, cells will be harvested from the patient from the peripheral blood, isolated and concentrated using proprietary Emcyte™ equipment/centrifugation, and then returned to the patient same day via the peripheral circulation. As circulation occurs, the concentrated cells enter the right heart and are then disseminated into the lungs, becoming trapped in the lung's microcirculation. Here, the cells are believed to produce multiple bioactive factors such as cytokines and anti-inflammatory mediators. Several growth factors are released by activated platelets becoming honing cells for healing within the tissue. The exact long-term mechanism of action of PRP-PC in the lungs remains under investigation. Safety studies have proven that autologous treatment is incredibly safe, largely because of the minimal cell manipulation and the autologous nature of the cells. Prior observational studies in this are have shown strong safety profiles as well as strong efficacy in both COPD and ILD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Objective(s) Primary

  • To determine if pulmonary function improves following ceullar therapy Secondary
  • To determine if participants' perceived quality of life related to breathing improves following cellular therapy To evaluate the safety of autologous PRP-PC administration for chronic lung disease

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33602
        • Centers for Respiratory Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Conventional treatment for chronic lung disease typically involves inhaled bronchodilators, steroids, oxygen therapy, antifibrotic medications, lung reduction surgery and lung transplantation for the management of symptoms, although none of these modalities (aside from surgery/transplant) thwarts long-term progression of the disease.. With transplantation the availability of donor lungs is scarce and the longterm need for anti-rejection medication and monitoring can be overwhelming. Recent advances in the field of regenerative medicine in lung disease have demonstrated that autologous cellular therapy may reduce inflammation and aid in the maintenance and repair of damaged lung tissue

Description

Inclusion Criteria:

  1. Subjects age 18 and older
  2. Diagnosis of COPD or an interstitial lung disease

Exclusion Criteria:

Pregnant subjects, subjects with an active cancer diagnosis except for basal cell skin cancer-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary Lung Function
Time Frame: 3 months
Lung function will be measured with spirometry to test FVC volume, FVC % predicted, FEV1 volume, and FEV1% predicted.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life subjective
Time Frame: 3 and 12 months
Quality of life will be measured with the Clinical COPD Questionnaire (CCQ).
3 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H-CYTE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2021

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

September 28, 2022

First Submitted That Met QC Criteria

September 28, 2022

First Posted (Actual)

October 3, 2022

Study Record Updates

Last Update Posted (Actual)

October 3, 2022

Last Update Submitted That Met QC Criteria

September 28, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCYTE LI-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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